As filed with the Securities and Exchange Commission on
September 7, 2022
Registration
No. 333-
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM S-8
REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933
AIkido Pharma, Inc.
(Exact Name of Registrant as Specified in its Charter)

Delaware |
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52-0849320 |
(State or Other Jurisdiction of
Incorporation or Organization) |
|
(I.R.S. Employer
Identification No.) |
One Rockefeller Plaza, 11th Floor
New York, NY 10020
(Address of Principal Executive Offices) (Zip Code)
AIkido Pharma, Inc. 2014 Equity Incentive Plan
(Full Title of the Plan)
Anthony Hayes
Chief Executive Officer
One Rockefeller Plaza, 11th Floor
New York, NY 10020
(Name and Address of Agent for Service)
(703) 992-9325
(Telephone Number, including area code, of agent for service)
Copies to:
Robert F. Charron, Esq.
Sarah Williams, Esq.
Ellenoff Grossman & Schole LLP
1345 Avenue of Americas, 11th Floor
New York, New York 10105
(212) 370-1300
Fax: (212) 370-7889
Indicate by check mark whether the Registrant is a large
accelerated filer, an accelerated filer, a non-accelerated filer, a
smaller reporting company or an emerging growth company. See
definitions of “large accelerated filer,”
“accelerated filer,” “smaller reporting company”
and “emerging growth company” in Rule 12b-2 of the
Exchange Act.
Large accelerated filer ☐ |
Accelerated filer ☐ |
Non-accelerated filer ☑ |
Smaller reporting company ☑ |
|
Emerging growth company ☐ |
If an emerging growth company, indicate by check mark if the
registrant has elected not to use the extended transition period
for complying with any new or revised financial accounting
standards provided pursuant to Section 7(a)(2)(B) of the Securities
Act. ☐
Explanatory Note
This Registration Statement on Form S-8 of AIkido Pharma, Inc.
(“we,” “us,” “our” or the “Company”) has been prepared in
accordance with the requirements of Form S-8 under the Securities
Act of 1933, as amended (the “Securities Act”), to (i) register
288,108 shares of our common stock, par value $0.0001 per share, to
be issued pursuant to the AIkido Pharma, Inc. 2014 Equity Incentive
Plan, as described in more detail herein, including registering for
resale pursuant to a reoffer prospectus certain securities to be
issued to our officers and directors upon exercise of outstanding
options or vesting of outstanding restricted stock units as
described below, and (ii) serve as a post-effective amendment,
pursuant to Rule 429 under the Securities Act, to our Registration
Statement on Form S-8 (File No. 333-210627) filed with the
Securities and Exchange Commission on April 6, 2016, and Form S-8
(File No. 333-197429) filed with the Securities and Exchange
Commission on July 15, 2014 covering an aggregate of 6,009 for the
purpose of adding a reoffer prospectus to each such registration
statement as described below.
This Registration Statement includes a reoffer prospectus prepared
in accordance with the requirements of Part I of Form S-3 (in
accordance with the General Instruction C to Form S-8). The reoffer
prospectus covers reoffers and resales of shares of our common
stock that have been or will be acquired by certain of our officers
and directors (collectively, the “selling stockholders”) which may
be deemed to be “control securities” and/or “restricted securities”
(as such terms are defined in General Instruction C to Form S-8) of
the Company. The reoffer prospectus relates to the
resale of up to 294,117 shares of common stock that have been or
may be issued to the selling stockholders pursuant to our stock
option plans.
PART I
INFORMATION REQUIRED IN THE SECTION 10(a) PROSPECTUS
Item 1. Plan Information.*
Item 2. Registrant Information and Employee Plan Annual
Information.*
* |
Pursuant to the Note to Part I on
Form S-8, the documents containing the information specified in
Part I of this Registration Statement will be sent or given to plan
participants as specified by Rule 428(b)(1) of the Securities Act
of 1934, as amended, or the Securities Act. Such documents are not
required to be filed, and are not filed, with the United States
Securities and Exchange Commission either as part of this
Registration Statement or as prospectuses or prospectus supplements
pursuant to Rule 424 of the Securities Act. These documents and the
documents incorporated by reference in this Registration Statement
pursuant to Item 3 of Part II of this Form S-8, taken together,
constitute a prospectus that meets the requirements of Section
10(a) of the Securities Act. |
Reoffer Prospectus

Up to 294,117 Shares of Common Stock under the AIkido Pharma,
Inc. 2014 Equity Incentive Plan
This reoffer prospectus is being used in connection with the
offering from time to time by certain selling stockholders of
AIkido, Inc., which we refer to herein as “we,” “us,” “our” or the
“Company,” or their successors in interest of shares of our common
stock, par value $0.0001 per share, which we refer to as the common
stock, issued or to be issued, or which may be acquired upon the
exercise of stock options or vesting of restricted stock units
issued or to be issued, pursuant to our AIkido Pharma, Inc. 2014
Equity Incentive Plan, which we refer to herein as the 2014 Plan.
The 2014 Plan is intended to provide incentives to attract, retain,
and motivate highly competent persons such as officers, employees,
directors, and consultants to our Company by providing them
opportunities to acquire shares of our common stock. Additionally,
the 2014 Plan is intended to assist in further aligning the
interests of our officers, employees, directors and consultants to
those of the Company’s other stockholders.
The common stock may be sold from time to time by the selling
stockholders or by their pledgees, donees, transferees or other
successors in interest. Such sales may be made in the market on
which our common stock is currently listed or otherwise at prices
and at terms then prevailing or at prices related to the then
current market price, or in negotiated transactions. The common
stock may be sold by one or more of the following: (a) block trades
in which the broker or dealer so engaged will attempt to sell the
shares as agent but may position and resell portions of the block
as principal to facilitate the transaction; (b) purchases by a
broker or dealer as principal and resale by such broker or dealer
for its account pursuant to this prospectus; (c) an exchange
distribution in accordance with the rules of such exchange; and (d)
ordinary brokerage transactions and transactions in which the
broker solicits purchases. In effecting sales, brokers or dealers
engaged by the selling stockholders may arrange for other brokers
or dealers to participate. Brokers or dealers will receive
commissions or discounts from selling stockholders in amounts to be
negotiated immediately prior to the sale. Such brokers or dealers
and any other participating brokers or dealers may be deemed to be
“underwriters” within the meaning of the Securities Act, in
connection with such sales. In addition, any securities covered by
this prospectus which qualify for sale pursuant to Rule 144 may be
sold under Rule 144 rather than pursuant to this prospectus. We
will not receive any of the proceeds from the sale of these shares,
although we have paid the expenses of preparing this prospectus and
the related Registration Statement. If any additional options are
issued to affiliates under the 2014 Plan or otherwise, we may file
with the Securities and Exchange Commission an update to this
prospectus naming such person as a selling shareholder and
indicating the number of shares such person is offering pursuant to
the prospectus. See “Selling Stockholders” on page 15 of this
prospectus.
Our common stock is listed on The Nasdaq Capital Market, or
Nasdaq, under the ticker symbol “AIKI.” On September 2, 2022, the
closing price of our common stock was $5.76.
Our principal executive offices are located at One Rockefeller
Plaza, 11th Floor, New York, NY 10020 and our telephone number is
(703) 992-9325.
Investing in our common stock involves a high degree of risk.
See the section entitled “Risk Factors” beginning on page
13 and in the documents incorporated by reference herein
before you decide to buy our common stock.
Neither the Securities and Exchange Commission nor any state
securities commission has approved or disapproved of these
securities or determined if this prospectus is truthful or
complete. Any representation to the contrary is a criminal
offense.
The date of this prospectus is September 7, 2022
TABLE OF CONTENTS
You should rely only upon the information contained in this reoffer
prospectus and the Registration Statement of which this reoffer
prospectus is a part. We have not authorized any other person to
provide you with different information. If anyone provides you with
different or inconsistent information, you should not rely on it.
We are not making an offer to sell these securities in any
jurisdiction where the offer or sale is not permitted. You should
assume the information appearing in this reoffer prospectus is
accurate only as of the date on the front cover of this reoffer
prospectus. Our business, financial condition, results of
operations and prospects may have changed since that date. This
reoffer prospectus is based on information provided by us and other
sources that we believe are reliable. We have summarized certain
documents and other information in a manner we believe to be
accurate, but we refer you to the actual documents for a more
complete understanding of what we discuss in this reoffer
prospectus. In making an investment decision, you must rely on your
own examination of our business and the terms of the offering,
including the merits and risks involved.
We obtained statistical data, market data and other industry data
and forecasts used throughout, or incorporated by reference in,
this reoffer prospectus from market research, publicly available
information and industry publications. Industry publications
generally state that they obtain their information from sources
that they believe to be reliable, but they do not guarantee the
accuracy and completeness of the information. Similarly, while we
believe that the statistical data, industry data and forecasts and
market research are reliable, we have not independently verified
the data, and we do not make any representation as to the accuracy
of the information. We have not sought the consent of the sources
to refer to their reports appearing or incorporated by reference in
this reoffer prospectus.
This reoffer prospectus contains, or incorporates by reference,
trademarks, tradenames, service marks and service names of AIkido
Pharma, Inc. and other companies.
Unless the context otherwise requires, “AIkido Pharma,” “AIKI,” the
“Company,” “we,” “us,” “our” and similar names refer to AIkido
Pharma, Inc. and its consolidated subsidiaries.
CAUTIONARY NOTE ON FORWARD
LOOKING STATEMENTS
This reoffer prospectus and the documents incorporated by reference
herein and therein may contain forward-looking statements that
involve risks and uncertainties. All statements other than
statements of historical fact contained in this reoffer prospectus
and the documents incorporated by reference herein and therein,
including statements regarding future events, our future financial
performance, business strategy, and plans and objectives of
management for future operations, are forward-looking statements.
We have attempted to identify forward-looking statements by
terminology including “anticipates,” “believes,” “can,” “continue,”
“could,” “estimates,” “expects,” “intends,” “may,” “plans,”
“potential,” “predicts,” “should,” or “will” or the negative of
these terms or other comparable terminology. Although we do not
make forward looking statements unless we believe we have a
reasonable basis for doing so, we cannot guarantee their accuracy.
These statements are only predictions and involve known and unknown
risks, uncertainties and other factors, including the risks
outlined under “Risk Factors” or elsewhere in this prospectus
supplement, the accompanying prospectus and the documents
incorporated by reference herein and therein, which may cause our
or our industry’s actual results, levels of activity, performance
or achievements expressed or implied by these forward-looking
statements. Moreover, we operate in a highly regulated, very
competitive, and rapidly changing environment. New risks emerge
from time to time and it is not possible for us to predict all risk
factors, nor can we address the impact of all factors on our
business or the extent to which any factor, or combination of
factors, may cause our actual results to differ materially from
those contained in any forward-looking statements. Risks that could
affect our business also include the duration and scope of the
COVID-19 pandemic and the impact on the demand for our technology;
actions by governments, businesses and individuals taken in
response to the pandemic; the length of time of the COVID-19
pandemic and the possibility of its reoccurrence; the timing
required to develop effective treatments and a vaccine in the event
of future outbreaks; the eventual impact of the pandemic and
actions taken in response to the pandemic on global and regional
economies; and the pace of recovery when the COVID-19 pandemic
subsides.
We have based these forward-looking statements largely on our
current expectations and projections about future events and
financial trends that we believe may affect our financial
condition, results of operations, business strategy, short term and
long term business operations, and financial needs. These
forward-looking statements are subject to certain risks and
uncertainties that could cause our actual results to differ
materially from those reflected in the forward-looking statements.
Factors that could cause or contribute to such differences include,
but are not limited to, those discussed in this reoffer prospectus
and the documents incorporated by reference herein, and in
particular, the risks discussed below and under the heading “Risk
Factors” and those discussed in other documents we file with the
SEC. The following discussion should be read in conjunction with
the financial statements for the fiscal years ended December 31,
2021 and 2020 and notes incorporated by reference therein. We
undertake no obligation to revise or publicly release the results
of any revision to these forward-looking statements, except as
required by law. In light of these risks, uncertainties and
assumptions, the forward-looking events and circumstances discussed
in this reoffer prospectus may not occur and actual results could
differ materially and adversely from those anticipated or implied
in the forward-looking statement.
You should not place undue reliance on any forward-looking
statement, each of which applies only as of the date of this
reoffer prospectus. Except as required by law, we undertake no
obligation to update or revise publicly any of the forward-looking
statements after the date of this reoffer prospectus to conform our
statements to actual results or changed expectations.
Any forward-looking statement you read in this reoffer prospectus
or any document incorporated by reference herein or therein
reflects our views at the time the forward-looking statement was
made with respect to future events and is subject to these and
other risks, uncertainties and assumptions relating to our
operations, operating results, growth strategy and liquidity. You
should not place undue reliance on these forward-looking statements
because such statements speak only as to the date when made. We
assume no obligation to publicly update or revise these
forward-looking statements for any reason, or to update the reasons
actual results could differ materially from those anticipated in
these forward-looking statements, even if new information becomes
available in the future, except as otherwise required by applicable
law. You are advised, however, to consult any further disclosures
we make on related subjects in our reports on Forms 10-Q, 8-K and
10-K filed with the SEC. You should understand that it is not
possible to predict or identify all risk factors. Consequently, you
should not consider any such list to be a complete set of all
potential risks or uncertainties.
PROSPECTUS SUMMARY
The following summary highlights selected information contained
or incorporated by reference in this reoffer prospectus. This
summary does not contain all of the information you should consider
before investing in the securities. Before making an investment
decision, you should read the entire reoffer prospectus and any
supplement hereto carefully, including the risk factors section as
well as the financial statements and the notes to the financial
statements incorporated herein by reference.
Business Overview
AIkido Pharma Inc., formerly known as Spherix Incorporated, was
initially formed in 1967. Since 2017, the Company has operated as a
biotechnology company with a diverse portfolio of small-molecule
anticancer and antiviral therapeutics in development. The Company’s
pipeline consists of patented technology from leading universities
and researchers. The Company’s innovative therapeutic drug pipeline
is currently being advanced through strong collaborations with
renowned educational institutions, including the University of
Texas at Austin, the University of Maryland, Baltimore and Wake
Forest University. The Company’s oncology therapeutics include
prospective treatments for pancreatic cancer, acute myeloid
leukemia (AML) and acute lymphoblastic leukemia (ALL). The Company
is also developing a broad-spectrum antiviral platform, in which
the lead compounds have activity in cell-based assays against
multiple viruses including Influenza virus, Ebolavirus and Marburg
virus, SARS-CoV, MERS-CoV, and SARS-CoV-2, the cause of
COVID-19.
As a result of the Company’s biotechnology research and development
and associated investments and acquisitions, its business portfolio
now focuses on the treatment of three different cancers and
multiple types of viral infections. The Company’s pancreatic drug
candidate, DHA-dFdC, developed at and licensed from the University
of Texas at Austin, is a new compound that it hopes will become the
next generation of chemotherapy treatment for advanced pancreatic
cancer. DHA-dFdC overcomes tumor cell resistance to current
chemotherapeutic drugs and is well tolerated in preclinical
toxicity tests. Preclinical studies have also indicated that
DHA-dFdC inhibits pancreatic cancer cell growth (up to 100,000-fold
more potent that gemcitabine, a current standard therapy),
accumulates preferentially in pancreatic tissue and has
demonstrated activities against other cancers, including leukemia,
lung and melanoma. The Company’s AML and ALL compound, developed at
the Wake Forest University, is a targeted therapeutic designed to
overcome multiple resistance mechanisms observed with the current
standard of care.
The Company previously focused its efforts on owning, developing,
acquiring and monetizing intellectual property assets. Since May
2016, the Company has received limited funds from its intellectual
property monetization. In addition to its patent monetization
efforts, since the fourth quarter of 2017, the Company has been
transitioning to focus its efforts as a technology and
biotechnology development company. These efforts have focused on
biotechnology research and blockchain technology research. The
Company’s biotechnology research development includes: (i) an
investment in Hoth Therapeutics Inc. (“Hoth”), a development stage
biopharmaceutical company focused on unique targeted therapeutics
for patients suffering from indications such as atopic dermatitis,
also known as eczema, (ii) an investment in DatChat, Inc.
(“DatChat”), a privately held personal privacy platform focused on
encrypted communication, internet security and digital rights
management, and (iii) the acquisition of assets of CBM BioPharma,
Inc. (“CBM”), a pharmaceutical company focusing on the development
of cancer treatments.
In addition, the Company owns an exclusive world-wide license to
patented technology from the University of Maryland Baltimore
(“UMB”). Our license is for a broad spectrum antiviral drug
platform. The licensed technology is a broadly acting pan-viral
inhibitory compound with efficacy against multiple viral pathogens.
The technology works to inhibit replication of multiple viruses
including Influenza virus, SARS-CoV (coronavirus), MERS-CoV,
Ebolavirus and Marburg virus. The technology is covered by two
patent applications already on file with the United States Patent
and Trademark Office. The UMB inventors are Drs. Matthew Frieman,
Alexander MacKerell and Stuart Watson. The Company has also
executed a Sponsored Research Agreement with UMB to support the
development of the technology.
Our Products and Services
The acquisition of the CBM assets has transformed the Company into
an innovative pharmaceutical company dedicated to translating
fundamental biological insights into new drugs and treatments that
address unmet medical needs. Our drug platform focuses on the
treatment of three cancers, including pancreatic cancer, acute
myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL).
Our Drug Platform
DHA-dFdC 4-(N)-Docosahexaenoyl 2´, 2´-Difluorodeoxycytidine,
referred to as DHA-dFdC, is patented technology licensed to the
Company from the University of Texas at Austin. DHA-dFdC is a new
compound poised to become the next generation of second-line
chemotherapy treatment for advanced pancreatic cancer. DHA-dFdC
overcomes tumor cell resistance to current chemotherapeutic drugs
and is well tolerated in preclinical toxicity tests. Preclinical
studies have also indicated that DHA-dFdC inhibits pancreatic
cancer cell growth (up to 100,000-fold more potent that
gemcitabine, a current standard therapy (for example, the IC50
value of DHA-dFdC is more than 100,000-fold smaller than
gemcitabine), has documented efficacy against pancreatic tumors in
a clinically relevant transgenic mouse model and has demonstrated
activities against other cancer cell lines, including leukemia,
lung and melanoma. Our AML and ALL compounds, developed at the Wake
Forest University and called KPC34, are next generation targeted
therapeutics designed to overcome multiple resistance mechanisms
observed with the current standard of care. Combined, the Company’s
drug platform offers a robust drug pipeline focused on the
development and commercialization of drugs to treat unmet medical
needs in oncology. In addition, we are constantly seeking to grow
our pipeline to treat unmet medical needs in oncology.
Background*
Pancreatic cancer is the 3rd leading cause of cancer-related death
in the United States, surpassing breast cancer. It is expected to
become the 2nd leading cause of cancer-related death in the United
States by the year 2020, surpassing colorectal cancer. In fact,
pancreatic cancer has the highest mortality rate of all major
cancers. Approximately 91% of pancreatic cancer patients will die
within five years of diagnosis, only 8% will survive more than five
years and 74% of patients die within the first year of
diagnosis.
Pancreatic cancer is one of the few cancers for which survival has
not improved substantially over nearly 40 years. Treatment options
for pancreatic cancer include surgery, radiation therapy and
chemotherapy, which extend survival or relieve symptoms, but seldom
produce a cure. Surgical removal of the tumor is possible in less
than 20% of patients diagnosed with pancreatic cancer because
detection is often in late stages and has spread beyond the
pancreas. The current state of the art chemotherapy treatment is
gemcitabine, Folfirinox cocktail or gemcitabine in combination with
Abraxane.
|
* |
Hirshberg Foundation for Pancreatic
Cancer Research |
The University of Texas at Austin has identified a new drug,
DHA-dFdC, that has shown positive results in preclinical studies,
inhibiting pancreatic tumor growth in clinically relevant
transgenic mouse models. In preclinical studies, DHA-dFdC has:
|
● |
inhibited pancreatic cancer cell
growth (up to 100,000-fold more potent that gemcitabine, a current
standard therapy); |
|
● |
has documented efficacy against
pancreatic tumors in a clinically relevant transgenic mouse
model; |
|
● |
has overcome tumor cell resistance
to current chemotherapeutic drugs; |
|
● |
is well tolerated in preclinical
toxicity test; |
|
● |
has demonstrated activities against
other cancers (e.g. leukemia, lung, melanoma); and |
|
● |
may stimulate immunogenic cell
death to activate host antitumor immunity. |
Gem-DHA Technology Summary
Gem-DHA is a conjugate molecule containing gemcitabine linked to a
fatty acid called docosahexaenoic acid (DHA). The structure is:

The DHA structure is illustrated above the dashed line in the
graphic above and the gemcitabine structure is illustrated below
the dashed line. The DHA patent states that Gem-DHA was more
effective than gemcitabine alone in killing cancer cells in vitro
and in vivo in a certain mouse model. The patent also states that
conjugation of gemcitabine with fatty acids other than DHA did not
increase effectiveness over gemcitabine.
Gem-DHA Published Data
The science behind Gem-DHA has been published in the following
peer-reviewed scientific journals:
|
● |
Naguib et al. (2016)
Synthesis, characterization, and in vitro and in vivo evaluations
of 4-(N)-docosahexaenoyl 2 ́, 2 ́- difluorodeoxycytidine with
potent and broad-spectrum antitumor activity, NeoPlasia 18:
33-48. |
|
● |
Valdes et al. (2017)
Preclinical evaluation of the short-term toxicity of
4-(N)-docosahexaenoyl 2 ́, 2 ́- difluorodeoxycytidine (DHA-dFdC),
Pharm. Res. 34: 1224-1232. |
|
● |
Valdes et al. (2019) A solid
lipid nanoparticle formulation of 4-(N)-docosahexaenoyl 2 ́, 2 ́-
difluorodeoxycytidine with increased solubility, stability, and
antitumor activity, Int. J. Pharm. 570:118609 |
The portions of the published data state the following:
|
● |
The drug unexpectedly concentrates
itself in the pancreas relative to other organs. |
|
● |
It significantly increases the
lifespan of mice with pancreatic cancer in either mice predisposed
to develop the cancer, or into which human pancreatic cancer has
been injected. |
|
● |
It significantly decreases the
growth of pancreatic tumors in mice, better than gemcitabine, the
current standard of care. |
|
● |
An oral formulation using lipid
nanoparticles is highly effective and stable and has outstanding
bioavailability. |
Gem-DHA Patent Coverage
Gem-DHA has one issued patent on the drug itself and one
application on the oral formulation, as listed in the following
table:
Number |
|
Priority |
|
Expiration |
|
Title |
App.
Serial No. 16/576,127, filed 9/19/2019 as continuation of App.
Serial No. 15/115,393, filed 1/29/2015 |
|
1/29/2014 |
|
N/A |
|
Nucleobase Analogue Derivatives and Their Applications |
U.S.
Patent No. 10,463,684, issued 11/5/2019 from App. Serial No.
15/115,393, filed 1/29/2015 |
|
1/29/2014 |
|
10/7/2035 |
|
Nucleobase Analogue Derivatives and Their Applications |
Provisional App. Serial No. 62/858,114, filed 6/6/2019 |
|
6/6/2019 |
|
N/A |
|
Lipid Nanoparticles Containing Pharmaceutical and/or
Nutraceutical agents and methods thereof |
All of this technology has been exclusively licensed to the Company
for commercial development.
AML & ALL Cancer
Our AML and ALL compounds, developed at the Wake Forest University
and called KPC34, are next generation targeted therapeutics
designed to overcome multiple resistance mechanisms observed with
the current standard of care.
Background
Approximately 70% of all AML patients are over the age of 60 and
only 6.6% of patients are still alive 5 years after diagnosis.
Gemcitabine and Cytarabine are the backbone of AML and ALL therapy,
but life expectancy is poor and relapses are much harder to
treat.
Cytarabine (Ara-C) has been a major drug for acute myeloid leukemia
(AML) treatment for more than three decades, but KPC34 has shown
superior results when tested against Cytarabine.
KPC34 Technology Summary
KPC34, a conjugate molecule made of a gemcitabine molecule linked
to a phospholipid, has the following structure:

Picture in the illustration above, to the left of the dashed line
is the phospholipid portion and to the right of the dashed line is
gemcitabine.
Gemcitabine is a chemotherapy drug used to treat a wide array of
cancers, including breast cancer, ovarian cancer, non-small cell
lung cancer, pancreatic cancer and bladder cancer. The drug
interferes with DNA and its function of the phospholipid to which
the gemcitabine is linked in KPC34, is to inhibit protein kinase
C-type enzymes, which are involved in multiple signaling pathways
in leukemia.
The strategy behind targeting both DNA synthesis and protein kinase
C with one molecule is to double-target different mechanisms of
action in leukemia cells and greatly reduce the possibility of
development of resistance to the drug.
KPC34 is intended to treat the relatively small population of
patients with AML and acute ALL. In 2019, an estimated 21,450
people of all ages (11,650 men and boys and 9,800 women and girls)
in the United States will be diagnosed with AML. AML is the second
most common type of leukemia diagnosed in adults and children, but
most cases occur in adults. AML makes up 32% of all adult leukemia
cases (source:
https://www.cancer.net/cancer-types/leukemia-acute-myeloid-aml/statistics).
In 2019, an estimated 5,930 people of all ages (3,280 men and boys
and 2,650 women and girls) in the United States were diagnosed with
ALL (source:
https://www.cancer.net/cancer-types/leukemia-acute-lymphocytic-all/statistics).
The drug is intended for oral application, unlike standard
chemotherapy drugs, which are given by injection.
Because of the low patient population, and the imminent expiration
of the patent, FDA orphan drug status will be sought, which
provides expedited review and seven years of exclusivity from
approval of the new drug application.
Preliminary data from preclinical studies at Wake Forest on the
drug includes the following results:
|
● |
kills leukemia cells in vitro; |
|
● |
inhibits protein kinase C in
biochemical assays; |
|
● |
has efficacy against ALL in a mouse
model when given orally; |
|
● |
has efficacy against central
nervous system leukemia in a mouse model when given orally; |
|
● |
has efficacy against AML exhibiting
phosphorylated protein kinase C in a mouse model when given
orally; |
|
● |
based on the mouse models, Wake
Forest claims KPC34 exhibited efficacy superior to gemcitabine
alone or cytarabine (another chemo drug) alone; and |
|
● |
KPC34 also appears to overcome
resistance to gemcitabine; it is effective against
gemcitabine-resistant cancer. |
The technology licensed is much broader than KPC34 represents, and
includes both anticancer and antiviral conjugates, and could
include a much broader range of indications, but we have no such
drug candidates in development other than KPC34.
KPC34 Patent Coverage
The KPC34 license includes five issued patents, but only one of
them covers KPC34. The patent is US7309696, entitled “Compositions
and methods for targeting cancer cells.” It expires on August 11,
2021. All five of the licensed patents will expire by late
2022.
Licenses
On April 12, 2018, CBM entered into a patent license agreement (the
“UT Agreement”) with the University of Texas at Austin on behalf of
the Board of Regents of the University of Texas System. The UT
Agreement granted to CBM an exclusive, royalty-bearing license to
certain patent applications related to nucleobase analogue
derivatives and their applications, and specifically to the
DHA-dFdC drug candidate. On November 13, 2019, the University of
Texas at Austin, the Company and CBM entered into an assignment of
agreement, whereby CBM assigned all of its rights, title and
interest to, and obligations under the UT Agreement to the
Company.
On April 17, 2018, CBM entered into a license agreement (the “WF
Agreement”) with Wake Forest University Health Sciences (“WF”). The
WF Agreement granted to CBM an exclusive, royalty-bearing license
to WF’s and The University of North Carolina at Chapel Hill’s
patents relating to the KPC34 drug candidate. On November 13, 2019,
WF, the Company and CBM entered into an assignment of agreement,
whereby CBM assigned all of its rights, title and interest to, and
obligations under the WF Agreement to the Company.
On April 13, 2020, the Company executed a Master License Agreement
(the “UMB License Agreement”) with UMB. The UMB License Agreement
covers certain antiviral compounds discovered by UMB. The compounds
seek to inhibit replication of multiple viruses, including
Influenza virus, SARS-CoV, MERS-CoV, Ebolavirus and Marburg virus.
The technology is covered by two patent applications already on
file with the United States Patent and Trademark Office. The UMB
inventors are Drs. Matthew Frieman, Alexander MacKerell and Stuart
Watson.
Commercialization
Our business success with our drug portfolio depends not only on
the successful development and approval of the products but also on
the commercialization. At present, our plan anticipates us making
the investments necessary to build an in-house marketing and sales
capability for the U.S. market for our drug pipeline, or to partner
with a larger drug development company to commercialize our drugs
as they move through the FDA approval process. As our drug
compounds make their way through clinical development in the U.S.,
we intend to approach pharmaceutical and biotechnology companies
outside the U.S. to negotiate and enter into strategic partnerships
that will enable development and commercialization of our platform
outside the U.S., where we believe the market opportunity is larger
than that of the U.S. albeit far more complex to reach. We have no
operations outside the U.S., nor are we planning to have any
non-U.S. operations.
Manufacturing and Supply
We do not have any manufacturing capabilities and therefore we will
have to engage a third party to assist in manufacturing. Such
manufacturing will need to be done in accordance with good
manufacturing practice requirements (“cGMP”) regulations, to
formulate and manufacture our product candidates. A list of third
party manufacturers is currently being developed.
Government Regulation
Governmental authorities in the U.S. and other countries
extensively regulate the research, development, testing,
manufacture, labeling, promotion, advertising, distribution and
marketing of pharmaceutical products such as those being developed
by us. In the U.S., the FDA regulates such products under the FDCA
and implements related regulations. Failure to comply with
applicable FDA requirements, both before and after approval, may
subject us to administrative and judicial sanctions, such as a
delay in approving or refusal by the FDA to approve pending
applications, warning letters, product recalls, product seizures,
total or partial suspension of production or distribution,
injunctions and/or criminal prosecution.
U.S. Food and Drug Administration Regulation
United States Drug Development
In the United States, the FDA regulates drugs, medical devices and
combinations of drugs and devices, or combination products, under
the FDCA and its implementing regulations. Drugs are also subject
to other federal, state and local statutes and regulations. The
process of obtaining regulatory approvals and the subsequent
compliance with appropriate federal, state, local and foreign
statutes and regulations requires the expenditure of substantial
time and financial resources. Failure to comply with the applicable
U.S. requirements at any time during the product development
process, approval process or after approval, may subject an
applicant to administrative or judicial sanctions. These sanctions
could include, among other actions, the FDA’s refusal to approve
pending applications, withdrawal of an approval, a clinical hold,
untitled or warning letters, requests for voluntary product recalls
or withdrawals from the market, product seizures, total or partial
suspension of production or distribution injunctions, fines,
refusals of government contracts, restitution, disgorgement, or
civil or criminal penalties. Any agency or judicial enforcement
action could have a material adverse effect on us.
|
● |
completion of extensive
pre-clinical laboratory tests, animal studies and formulation
studies in accordance with applicable regulations, including the
FDA’s Good Laboratory Practice regulations; |
|
● |
submission to the FDA of an IND,
which must become effective before human clinical trials may
begin; |
|
● |
performance of adequate and
well-controlled human clinical trials in accordance with an
applicable IND and other clinical study related regulations,
sometimes referred to as good clinical practices, or GCPs, to
establish the safety and efficacy of the proposed drug for its
proposed indication; |
|
● |
submission to the FDA of an
NDA; |
|
● |
satisfactory completion of an FDA
pre-approval inspection of the manufacturing facility or facilities
at which the product, or components thereof, are produced to assess
compliance with the FDA’s cGMP requirements; |
|
● |
potential FDA audit of the clinical
trial sites that generated the data in support of the NDA; and |
|
● |
FDA review and approval of the NDA
prior to any commercial marketing or sale. |
Once a pharmaceutical product candidate is identified for
development, it enters the pre-clinical testing stage. Pre-clinical
tests include laboratory evaluations of product chemistry,
toxicity, formulation and stability, as well as animal studies. An
IND sponsor must submit the results of the pre-clinical tests,
together with manufacturing information, analytical data and any
available clinical data or literature, to the FDA as part of the
IND. The sponsor must also include a protocol detailing, among
other things, the objectives of the initial clinical trial, the
parameters to be used in monitoring safety and the effectiveness
criteria to be evaluated if the initial clinical trial lends itself
to an efficacy evaluation. Some pre-clinical testing may continue
even after the IND is submitted. The IND automatically becomes
effective 30 days after receipt by the FDA, unless the FDA raises
concerns or questions related to a proposed clinical trial and
places the trial on a clinical hold within that 30-day period. In
such a case, the IND sponsor and the FDA must resolve any
outstanding concerns before the clinical trial can begin. Clinical
holds also may be imposed by the FDA at any time before or during
clinical trials due to safety concerns or non-compliance, and may
be imposed on all drug products within a certain class of drugs.
The FDA also can impose partial clinical holds, for example,
prohibiting the initiation of clinical trials of a certain duration
or for a certain dose.
All clinical trials must be conducted under the supervision of one
or more qualified investigators in accordance with GCP regulations.
These regulations include the requirement that all research
subjects provide informed consent in writing before their
participation in any clinical trial. Further, an IRB must review
and approve the plan for any clinical trial before it commences at
any institution, and the IRB must conduct continuing review and
reapprove the study at least annually. An IRB considers, among
other things, whether the risks to individuals participating in the
clinical trial are minimized and are reasonable in relation to
anticipated benefits. The IRB also approves the information
regarding the clinical trial and the consent form that must be
provided to each clinical trial subject or his or her legal
representative and must monitor the clinical trial until
completed.
Each new clinical protocol and any amendments to the protocol must
be submitted for FDA review, and to the IRBs for approval.
Protocols detail, among other things, the objectives of the
clinical trial, dosing procedures, subject selection and exclusion
criteria, and the parameters to be used to monitor subject
safety.
Human clinical trials are typically conducted in three sequential
phases that may overlap or be combined:
|
● |
Phase 1. The product is initially
introduced into a small number of healthy human subjects or
patients and tested for safety, dosage tolerance, absorption,
metabolism, distribution and excretion and, if possible, to gain
early evidence on effectiveness. In the case of some products for
severe or life-threatening diseases, especially when the product is
suspected or known to be unavoidably toxic, the initial human
testing may be conducted in patients. |
|
● |
Phase 2. Involves clinical trials
in a limited patient population to identify possible adverse
effects and safety risks, to preliminarily evaluate the efficacy of
the product for specific targeted diseases and to determine dosage
tolerance and optimal dosage and schedule. |
|
● |
Phase 3. Clinical trials are
undertaken to further evaluate dosage, clinical efficacy and safety
in an expanded patient population at geographically dispersed
clinical trial sites. These clinical trials are intended to
establish the overall risk/benefit relationship of the product and
provide an adequate basis for product labeling. |
Post-approval trials, sometimes referred to as Phase 4 clinical
trials, may be conducted after initial marketing approval. These
studies are used to gain additional experience from the treatment
of patients in the intended therapeutic indication. In certain
instances, the FDA may mandate the performance of Phase 4 trials.
Companies that conduct certain clinical trials also are required to
register them and post the results of completed clinical trials on
a government-sponsored database, such as ClinicalTrials.gov in the
United States, within certain timeframes. Failure to do so can
result in fines, adverse publicity and civil and criminal
sanctions.
Progress reports detailing the results of the clinical trials,
among other information, must be submitted at least annually to the
FDA, and written IND safety reports must be submitted to the FDA
and the investigators for serious and unexpected adverse events,
findings from other studies that suggest a significant risk to
humans exposed to the product, findings from animal or in vitro
testing that suggest a significant risk to human subjects, and any
clinically important increase in the rate of a serious suspected
adverse reaction over that listed in the protocol or investigator
brochure. Phase 1, Phase 2 and Phase 3 clinical trials may not be
completed successfully within any specified period, if at all. The
FDA or the clinical trial sponsor may suspend or terminate a
clinical trial at any time on various grounds, including a finding
that the research subjects or patients are being exposed to an
unacceptable health risk. Similarly, an IRB can suspend or
terminate approval of a clinical trial at its institution if the
clinical trial is not being conducted in accordance with the IRB’s
requirements or if the product has been associated with unexpected
serious harm to patients. Additionally, some clinical trials are
overseen by an independent group of qualified experts organized by
the clinical trial sponsor, known as a data safety monitoring board
or committee. This group provides authorization for whether a trial
may move forward at designated check points based on access to
certain data from the study. The clinical trial sponsor may also
suspend or terminate a clinical trial based on evolving business
objectives and/or competitive climate.
Concurrent with clinical trials, companies usually complete
additional animal studies and must also develop additional
information about the chemistry and physical characteristics of the
product and finalize a process for manufacturing the product in
commercial quantities in accordance with cGMP requirements. The
manufacturing process must be capable of consistently producing
quality batches of the product candidate and, among other things,
the manufacturer must develop methods for testing the identity,
strength, quality and purity of the final product. Additionally,
appropriate packaging must be selected and tested and stability
studies must be conducted to demonstrate that the product candidate
does not undergo unacceptable deterioration over its shelf
life.
NDA and FDA Review Process
The results of product development, pre-clinical studies and
clinical trials, along with descriptions of the manufacturing
process, analytical tests conducted on the drug, proposed labeling
and other relevant information, are submitted to the FDA as part of
an NDA for a new drug, requesting approval to market the product.
The submission of an NDA is subject to the payment of a substantial
user fee, and the sponsor of an approved NDA is also subject to an
annual program user fee; although a waiver of such fee may be
obtained under certain limited circumstances. For example, the
agency will waive the application fee for the first human drug
application that a small business or its affiliate submits for
review.
The FDA reviews all NDAs submitted before it accepts them for
filing and may request additional information rather than accepting
an NDA for filing. The FDA typically makes a decision on accepting
an NDA for filing within 60 days of receipt. The decision to accept
the NDA for filing means that the FDA has made a threshold
determination that the application is sufficiently complete to
permit a substantive review. Under the goals and policies agreed to
by the FDA under the Prescription Drug User Fee Act (“PDUFA”), the
FDA’s goal to complete its substantive review of a standard NDA and
respond to the applicant is ten months from the receipt of the NDA.
The FDA does not always meet its PDUFA goal dates, and the review
process is often significantly extended by FDA requests for
additional information or clarification and may go through multiple
review cycles.
After the NDA submission is accepted for filing, the FDA reviews
the NDA to determine, among other things, whether the proposed
product is safe and effective for its intended use, and whether the
product is being manufactured in accordance with cGMPs to assure
and preserve the product’s identity, strength, quality and purity.
The FDA may refer applications for novel drug products or drug
products which present difficult questions of safety or efficacy to
an advisory committee, typically a panel that includes clinicians
and other experts, for review, evaluation and a recommendation as
to whether the application should be approved and under what
conditions. The FDA is not bound by the recommendations of an
advisory committee, but it considers such recommendations carefully
when making decisions. The FDA will likely re-analyze the clinical
trial data, which could result in extensive discussions between the
FDA and us during the review process. The review and evaluation of
an NDA by the FDA is extensive and time consuming and may take
longer than originally planned to complete, and we may not receive
a timely approval, if at all.
Before approving an NDA, the FDA will conduct a pre-approval
inspection of the manufacturing facilities for the new product to
determine whether they comply with cGMPs. The FDA will not approve
the product unless it determines that the manufacturing processes
and facilities are in compliance with cGMP requirements and
adequate to assure consistent production of the product within
required specifications. In addition, before approving an NDA, the
FDA may also audit data from clinical trials to ensure compliance
with GCP requirements. After the FDA evaluates the application,
manufacturing process and manufacturing facilities, it may issue an
approval letter or a Complete Response Letter. An approval letter
authorizes commercial marketing of the drug with specific
prescribing information for specific indications. A Complete
Response Letter indicates that the review cycle of the application
is complete and the application will not be approved in its present
form. A Complete Response Letter usually describes all the specific
deficiencies in the NDA identified by the FDA. The Complete
Response Letter may require additional clinical data and/or an
additional pivotal Phase 3 clinical trial(s), and/or other
significant and time-consuming requirements related to clinical
trials, nonclinical studies or manufacturing. If a Complete
Response Letter is issued, the applicant may either resubmit the
NDA, addressing all the deficiencies identified in the letter, or
withdraw the application. Even if such data and information are
submitted, the FDA may ultimately decide that the NDA does not
satisfy the criteria for approval. Data obtained from clinical
trials are not always conclusive, and the FDA may interpret data
differently than we interpret the same data.
There is no assurance that the FDA will ultimately approve a
product for marketing in the United States, and we may encounter
significant difficulties or costs during the review process. If a
product receives marketing approval, the approval may be
significantly limited to specific diseases and dosages or the
indications for use may otherwise be limited, which could restrict
the commercial value of the product. Further, the FDA may require
that certain contraindications, warnings or precautions be included
in the product labeling or may condition the approval of the NDA on
other changes to the proposed labeling, development of adequate
controls and specifications, or a commitment to conduct post-market
testing or clinical trials and surveillance to monitor the effects
of approved products. For example, the FDA may require Phase 4
clinical trials to further assess drug safety and effectiveness and
may require testing and surveillance programs to monitor the safety
of approved products that have been commercialized. The FDA may
also place other conditions on approvals, including the requirement
for a risk evaluation and mitigation strategy (“REMS”), to assure
the safe use of the drug. If the FDA concludes a REMS is needed,
the sponsor of the NDA must submit a proposed REMS; the FDA will
not approve the NDA without an approved REMS, if required. A REMS
could include medication guides, physician communication plans, or
elements to assure safe use, such as restricted distribution
methods, patient registries and other risk minimization tools. Any
of these limitations on approval or marketing could restrict the
commercial promotion, distribution, prescription or dispensing of
products. Product approvals may be withdrawn for non-compliance
with regulatory requirements or if problems occur following initial
marketing.
Reimbursement
Potential sales of any of our product candidates, if approved, will
depend, at least in part, on the extent to which such products will
be covered by third-party payors, such as government health care
programs, commercial insurance and managed healthcare
organizations. These third-party payors are increasingly limiting
coverage and/or reducing reimbursements for medical products and
services. A third-party payor’s decision to provide coverage for a
drug product does not imply that an adequate reimbursement rate
will be approved. Further, one payor’s determination to provide
coverage for a drug product does not assure that other payors will
also provide coverage for the drug product. In addition, the U.S.
government, state legislatures and foreign governments have
continued implementing cost-containment programs, including price
controls, restrictions on reimbursement and requirements for
substitution of generic products. Adoption of price controls and
cost-containment measures, and adoption of more restrictive
policies in jurisdictions with existing controls and measures,
could further limit our future revenues and results of operations.
Decreases in third-party reimbursement or a decision by a
third-party payor to not cover a product candidate, if approved, or
any future approved products could reduce physician usage of our
products, and have a material adverse effect on our sales, results
of operations and financial condition.
In the United States, the Medicare Part D program provides a
voluntary outpatient drug benefit to Medicare beneficiaries for
certain products. We do not know whether our product candidates, if
approved, will be eligible for coverage under Medicare Part D, but
individual Medicare Part D plans offer coverage subject to various
factors such as those described above. Furthermore, private payors
often follow Medicare coverage policies and payment limitations in
setting their own coverage policies.
Pediatric Exclusivity and Pediatric Use
The Pediatric Research Equity Act, or PREA, requires a sponsor to
conduct pediatric studies for most drugs and biologics, for a new
active ingredient, new indication, new dosage form, new dosing
regimen or new route of administration. Under PREA, original NDAs,
biologics license applications and supplements thereto, must
contain a pediatric assessment unless the sponsor has received a
deferral or waiver. Unless otherwise required by regulation, PREA
does not apply to any drug for an indication for which an orphan
drug designation has been granted. The required assessment must
assess the safety and effectiveness of the product for the claimed
indications in all relevant pediatric subpopulations and support
dosing and administration for each pediatric subpopulation for
which the product is safe and effective. The sponsor or FDA may
request a deferral of pediatric studies for some or all of the
pediatric subpopulations. A deferral may be granted for several
reasons, including a finding that the drug or biologic is ready for
approval for use in adults before pediatric studies are complete or
that additional safety or effectiveness data needs to be collected
before the pediatric studies begin.
Pediatric exclusivity is another type of non-patent marketing
exclusivity in the United States and, if granted, provides for the
attachment of an additional six months of marketing protection to
the term of any existing regulatory exclusivity, including the
non-patent and orphan exclusivity. This six-month exclusivity may
be granted if an NDA sponsor submits pediatric data that fairly
respond to a written request from the FDA for such data. The data
does not need to show the product to be effective in the pediatric
population studied; rather, if the clinical trial is deemed to
fairly respond to the FDA’s request, the additional protection is
granted. If reports of requested pediatric studies are submitted to
and accepted by the FDA within the statutory time limits, whatever
statutory or regulatory periods of exclusivity or patent protection
cover the product are extended by six months.
Healthcare Laws and Regulations
Sales of our product candidates, if approved, or any other future
product candidate will be subject to healthcare regulation and
enforcement by the federal government and the states and foreign
governments in which we might conduct our business. The healthcare
laws and regulations that may affect our ability to operate include
the following:
|
● |
The federal Anti-Kickback Statute
makes it illegal for any person or entity to knowingly and
willfully, directly or indirectly, solicit, receive, offer, or pay
any remuneration that is in exchange for or to induce the referral
of business, including the purchase, order, lease of any good,
facility, item or service for which payment may be made under a
federal healthcare program, such as Medicare or Medicaid. The term
“remuneration” has been broadly interpreted to include anything of
value. |
|
● |
Federal false claims and false
statement laws, including the federal civil False Claims Act,
prohibits, among other things, any person or entity from knowingly
presenting, or causing to be presented, for payment to, or approval
by, federal programs, including Medicare and Medicaid, claims for
items or services, including drugs, that are false or
fraudulent. |
|
● |
Health Insurance Portability and
Accountability Act of 1996 (“HIPAA”) created additional federal
criminal statutes that prohibit among other actions, knowingly and
willfully executing, or attempting to execute, a scheme to defraud
any healthcare benefit program, including private third-party
payors or making any false, fictitious or fraudulent statement in
connection with the delivery of or payment for healthcare benefits,
items or services. |
|
● |
HIPAA, as amended by the Health
Information Technology for Economic and Clinical Health Act of 2009
and their implementing regulations, impose obligations on certain
types of individuals and entities regarding the electronic exchange
of information in common healthcare transactions, as well as
standards relating to the privacy and security of individually
identifiable health information. |
|
● |
The federal Physician Payments
Sunshine Act requires certain manufacturers of drugs, devices,
biologics and medical supplies for which payment is available under
Medicare, Medicaid or the Children’s Health Insurance Program, with
specific exceptions, to report annually to the Centers for Medicare
& Medicaid Services information related to payments or other
transfers of value made to physicians and teaching hospitals, as
well as ownership and investment interests held by physicians and
their immediate family members. |
Also, many states have similar laws and regulations, such as
anti-kickback and false claims laws that may be broader in scope
and may apply regardless of payor, in addition to items and
services reimbursed under Medicaid and other state programs.
Additionally, we may be subject to state laws that require
pharmaceutical companies to comply with the federal government’s
and/or pharmaceutical industry’s voluntary compliance guidelines,
state laws that require drug manufacturers to report information
related to payments and other transfers of value to physicians and
other healthcare providers or marketing expenditures, as well as
state and foreign laws governing the privacy and security of health
information, many of which differ from each other in significant
ways and often are not preempted by HIPAA.
Additionally, to the extent that our product is sold in a foreign
country, we may be subject to similar foreign laws.
Corporate Information
We were incorporated in Delaware on May 1, 1992. Our principal
executive offices are located at One Rockefeller Plaza, 11th Floor,
New York, New York 10020, and our telephone number is (703)
992-9325. Our corporate website address is www.aikidopharma.com.
The information contained on or accessible through our website is
not a part of this prospectus, and the inclusion of our website
address in this prospectus is an inactive textual reference
only.
The Offering
Outstanding Common Stock |
As of September 2,
2022, there were 5,485,096 shares of common stock
issued and outstanding. |
|
|
Common Stock Offered |
Up to 294,117 shares of common
stock for sale by the selling stockholders for their own
account. |
|
|
Selling Stockholders |
The selling stockholders are set
forth in the Section entitled “Selling Stockholders” of this
reoffer prospectus on page 15. |
|
|
Proceeds |
We will not receive any proceeds
from the sale of our common stock by the selling stockholders. We
would, however, receive proceeds upon the exercise of the stock
options by those who receive or received options under the 2014
Plan and exercise such options for cash. Any cash proceeds will be
used by us for general corporate purposes. |
|
|
Risk Factors |
The securities offered hereby
involve a high degree of risk. See “Risk Factors.” |
|
|
Nasdaq Symbol |
AIKI |
Unless otherwise indicated, all share numbers in this registration
statement takes into consideration all reverse stock splits
effectuated by the Company since the inception of the 2014
Plan.
RISK FACTORS
Investing in our common stock involves risk. Before deciding
whether to invest in our common stock, you should consider the
risks, uncertainties and assumptions discussed under the
heading “Risk Factors” in our Quarterly Reports on
Form 10-Q for the fiscal quarters ended March 31, 2022 and June 30,
2022 and our Annual Report on Form 10-K for the fiscal year ended
December 31, 2021, each as incorporated by reference in this
reoffer prospectus, any amendment or update thereto reflected in
subsequent filings with the SEC, including in our annual reports on
Form 10-K and quarterly reports on Form 10-Q, and all other
information contained or incorporated by reference in this reoffer
prospectus, as updated by our subsequent filings under the
Securities and Exchange Act of 1934, as amended (referred to herein
as the Exchange Act). There may be other unknown or unpredictable
economic, business, competitive, regulatory or other factors that
could have material adverse effects on our future results. If any
of these risks actually occurs, our business, business prospects,
financial condition or results of operations could be seriously
harmed. This could cause the trading price of our common stock to
decline, resulting in a loss of all or part of your investment.
Please also read carefully the section above entitled
“Cautionary Note on Forward-Looking Statements.”
USE OF PROCEEDS
The shares which may be sold under this reoffer prospectus will be
sold for the respective accounts of each of the selling
stockholders listed herein (who are our executive officers and
directors). Accordingly, we will not realize any proceeds from the
sale of the shares of our common stock. We will receive proceeds
from the exercise of the options; however, no assurance can be
given as to when or if any or all of the options will be exercised.
If any options are exercised, the proceeds derived therefrom will
be used for working capital and general corporate purposes. All
expenses of the registration of the shares will be paid by us. See
“Selling Stockholders” and “Plan of Distribution.”
SELLING
STOCKHOLDERS
This reoffer prospectus relates to the shares of our common stock
that are being registered for reoffers and resale by selling
stockholders who have acquired or may acquire shares pursuant to
the 2014 Plan. Offers and sales by selling stockholders who are our
employees, consultants and “affiliates” (as such term is defined in
Rule 405 under the Securities Act) are also covered by this reoffer
prospectus.
The selling stockholders are our current directors, officers and
affiliates who have acquired or may acquire in the future shares of
our common stock under the 2014 Plan. The selling stockholders may,
from time to time, resell all, a portion or none of the shares of
our common stock covered by this reoffer prospectus. The following
table sets forth information as of September 2, 2022 with respect
to ownership of our common stock by each selling stockholder
whose identity is known as of the date of this reoffer prospectus.
There is no assurance that any of the selling stockholders will
sell any or all of the shares offered by them under this
Registration Statement. The address for each selling stockholders
listed below is c/o AIkido Pharma, Inc., One Rockefeller Plaza,
11th Floor, New York, New York 10020.
Any changed information will be set forth in an amendment to the
Registration Statement or supplement to this reoffer prospectus, to
the extent required by law. Inclusion of an individual’s name in
the table below does not constitute an admission that such
individual is an “affiliate” of the Company.
Name |
|
Number of
Shares
Owned (1) |
|
|
Number of
Shares to be
Offered for
the Account
of the Selling
Stockholder (2) |
|
|
Number of
Shares to
be Owned
After
Offering |
|
|
% Owned
After
Offering (3) |
|
Robert J. Vander Zanden
(4) |
|
|
12,702 |
|
|
|
12,688 |
|
|
|
12,702 |
|
|
|
* |
|
Anthony Hayes (5) |
|
|
84,016 |
|
|
|
82,043 |
|
|
|
84,016 |
|
|
|
1.56 |
% |
Tim S. Ledwick (6) |
|
|
12,826 |
|
|
|
12,688 |
|
|
|
12,826 |
|
|
|
* |
|
Paul LeMire (7) |
|
|
12,411 |
|
|
|
12,411 |
|
|
|
12,411 |
|
|
|
* |
|
Robert Dudley (8) |
|
|
12,411 |
|
|
|
12,411 |
|
|
|
12,411 |
|
|
|
* |
|
Gregory Blattner (9) |
|
|
12,411 |
|
|
|
12,411 |
|
|
|
12,411 |
|
|
|
* |
|
Kyle Wool (10 ) |
|
|
80,058 |
|
|
|
80,058 |
|
|
|
80,058 |
|
|
|
* |
|
Soo Yu (11) |
|
|
8,000 |
|
|
|
8,000 |
|
|
|
8,000 |
|
|
|
* |
|
Christopher Devall (12) |
|
|
8,068 |
|
|
|
8,068 |
|
|
|
8,068 |
|
|
|
* |
|
Carlos Aldovero (13) |
|
|
25,000 |
|
|
|
25,000 |
|
|
|
25,000 |
|
|
|
* |
|
|
(1) |
Represents common stock owned on or
about the date hereof by the Selling Stockholders and shares of
common stock that are issued or to be issued, or which may be
acquired upon the exercise of stock options issued or to be issued,
or vesting of restricted stock awards issued or to be issued,
pursuant to the 2014 Plan as of September 2, 2022. |
|
(2) |
Represents only shares of common
stock that are issued or to be issued, or which may be acquired
upon the exercise of stock options issued or to be issued, or
vesting of restricted stock awards issued or to be issued, pursuant
to the 2014 Plan. These shares constitute “control
securities” as such term is defined in General Instruction C
to Form S-8. |
|
(3) |
Percentage is computed with
reference to 5,485,096 shares of our Common Stock outstanding as of
September 2, 2022 and assumes for each Selling Stockholder the sale
of all shares offered by that particular Selling Stockholder under
the Prospectus. |
|
(4) |
Dr. Robert J. Vander Zanden is our
Chairman of our Board and a member of our Board of Directors. The
securities to be registered for resale by Mr. Zanden include 9,747
shares of common stock issued pursuant to the 2014 Plan and 2,941
shares of common stock issuable upon exercise of outstanding vested
options issued pursuant to the 2014 Plan. |
|
(5) |
Anthony Hayes is our Chief
Executive Officer, Principal Accounting Officer, Principal
Financial officer, and a member of our Board of Directors. The
securities to be registered for resale by Mr. Hayes include 79,102
shares of common stock issued pursuant to the 2014 Plan and 2,941
shares of common stock issued upon exercise of outstanding vested
options issued pursuant to the 2014 Plan. |
|
(6) |
Tim S. Ledwick a member of our
Board of Directors. The securities to be registered for resale by
Mr. Ledwick include 9,747 shares of common stock issued pursuant to
the 2014 Plan and 2,941 shares of common stock issuable upon
exercise of outstanding vested options issued pursuant to the 2014
Plan. |
|
(7) |
Gregory James Blattner is a member
of our Board of Directors. The securities to be registered for
resale by Mr. Blattner include 9,470 shares of common stock issued
pursuant to the 2014 Plan and 2,941 shares of common stock issuable
upon exercise of outstanding vested options issued pursuant to the
2014 Plan. |
|
(8) |
Paul LeMire is a member of our
Board of Directors. The securities to be registered for resale by
Mr. LeMire include 9,470 shares of common stock issued pursuant to
the 2014 Plan and 2,941 shares of common stock issuable upon
exercise of outstanding vested options issued pursuant to the 2014
Plan. |
|
(9) |
Robert Dudley is a member of our
Board of Directors. The securities to be registered for resale by
Mr. Dudley include 9,470 shares of common stock issued pursuant to
the 2014 Plan and 2,941 shares of common stock issuable upon
exercise of outstanding vested options issued pursuant to the 2014
Plan. |
|
(10) |
Kyle Wool is a member of our Board
of Directors. The securities to be registered for resale by Mr.
Wool include 80,058 shares of common stock issued pursuant to the
2014 Plan. |
(11) |
Soo
Yu is a member of our Board of Directors. The securities to be
registered for resale by Ms. Yu include 8,000 shares of common
stock issued pursuant to the 2014 Plan. |
(12) |
Christopher
Devall is our Vice President of Operations. The securities to be
registered for resale by Mr. Devall include 8,068 shares of common
stock issued pursuant to the 2014 Plan. |
(13) |
Carlos
Aldovero is the Chief Executive Officer of one of our subsidiaries.
The securities to be registered for resale by Mr. Aldovero include
25,000 shares of common stock issued pursuant to the 2014
Plan. |
PLAN OF
DISTRIBUTION
In this section of the reoffer prospectus, the term “selling
stockholder” means and includes:
|
● |
the persons identified in the table
above as the selling stockholders; |
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|
● |
those persons whose identities are
not known as of the date hereof but may in the future be eligible
to receive options under the 2014 Plan; and |
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|
● |
any of the purchasers, assignees,
donees, pledgees, distributees, transferees or other successors in
interest of those persons referenced above who may: (a) receive any
of the shares of our common stock offered hereby after the date of
this reoffer prospectus and (b) offer or sell those shares
hereunder. |
The shares of our common stock offered by this reoffer prospectus
may be sold from time to time directly by the selling stockholders.
Alternatively, the selling stockholders may from time to time offer
such shares through underwriters, brokers, dealers, agents or other
intermediaries. The selling stockholders as of the date of this
reoffer prospectus have advised us that there were no underwriting
or distribution arrangements entered into with respect to the
common stock offered hereby. The distribution of the common stock
by the selling stockholders may be effected: in one or more
transactions that may take place on Nasdaq or any other stock
exchange (including one or more block transaction) through
customary brokerage channels, either through brokers acting as
agents for the selling stockholders, or through market makers,
dealers or underwriters acting as principals who may resell these
shares on Nasdaq or any other stock exchange; in
privately-negotiated sales; by a combination of such methods; or by
other means. These transactions may be effected at market prices
prevailing at the time of sale, at prices related to such
prevailing market prices or at other negotiated prices. Usual and
customary or specifically negotiated brokerage fees or commissions
may be paid by the selling stockholders in connection with sales of
our common stock.
The selling stockholders may enter into hedging transactions with
broker-dealers in connection with distributions of the shares or
otherwise. In such transactions, broker-dealers may engage in short
sales of the shares of our common stock in the course of hedging
the positions they assume with the selling stockholders. The
selling stockholders also may sell shares short and redeliver the
shares to close out such short positions. The selling stockholders
may enter into option or other transactions with broker-dealers
which require the delivery to the broker-dealer of shares of our
common stock. The broker-dealer may then resell or otherwise
transfer such shares of common stock pursuant to this reoffer
prospectus.
The selling stockholders also may lend or pledge shares of our
common stock to a broker-dealer. The broker-dealer may sell the
shares of common stock so lent, or upon a default the broker-dealer
may sell the pledged shares of common stock pursuant to this
reoffer prospectus. Any securities covered by this reoffer
prospectus which qualify for sale pursuant to Rule 144 may be sold
under Rule 144 rather than pursuant to this reoffer prospectus.
The selling stockholders have advised us that they have not entered
into any agreements, understandings or arrangements with any
underwriters or broker-dealers regarding the sale of their
securities. There is no underwriter or coordinating broker acting
in connection with the proposed sale of shares of common stock the
selling stockholders.
Although the shares of common stock covered by this reoffer
prospectus are not currently being underwritten, the selling
stockholders or their underwriters, brokers, dealers or other
agents or other intermediaries, if any, that may participate with
the selling security holders in any offering or distribution of
common stock may be deemed “underwriters” within the meaning of the
Securities Act and any profits realized or commissions received by
them may be deemed underwriting compensation there under.
Under applicable rules and regulations under the Exchange Act, any
person engaged in a distribution of shares of the common stock
offered hereby may not simultaneously engage in market making
activities with respect to the common stock for a period of up to
five days preceding such distribution. The selling stockholders
will be subject to the applicable provisions of the Exchange Act
and the rules and regulations promulgated there under, including
without limitation Regulation M, which provisions may limit the
timing of purchases and sales by the selling stockholders.
In order to comply with certain state securities or blue sky laws
and regulations, if applicable, the common stock offered hereby
will be sold in such jurisdictions only through registered or
licensed brokers or dealers. In certain states, the common stock
may not be sold unless they are registered or qualified for sale in
such state, or unless an exemption from registration or
qualification is available and is obtained.
We will bear all costs, expenses and fees in connection with the
registration of the common stock offered hereby. However, the
selling stockholders will bear any brokerage or underwriting
commissions and similar selling expenses, if any, attributable to
the sale of the shares of common stock offered pursuant to this
reoffer prospectus. We have agreed to indemnify certain of the
selling security holders against certain liabilities, including
liabilities under the Securities Act, or to contribute to payments
to which any of those security holders may be required to make in
respect thereof.
There can be no assurance that the selling stockholders will sell
any or all of the securities offered by them hereby.
LEGAL MATTERS
The validity of the securities being offered herein has been passed
upon for us by Ellenoff Grossman & Schole LLP, New York,
New York.
EXPERTS
The consolidated financial statements of AIkido Pharma, Inc. as of
and for the years ended December 31, 2021 and 2020 incorporated by
reference in this Prospectus and in the Registration Statement have
been so incorporated by reference in reliance on the report of
WithumSmith+Brown PC and Marcum, LLP, independent registered public
accounting firms, incorporated by reference herein, given on the
authority of said firm as experts in auditing and accounting.
INCORPORATION OF CERTAIN
DOCUMENTS BY REFERENCE
We are “incorporating by reference” in this reoffer prospectus
certain documents we file with the SEC, which means that we can
disclose important information to you by referring you to those
documents. The information in the documents incorporated by
reference is considered to be part of this reoffer prospectus.
Statements contained in documents that we file with the SEC and
that are incorporated by reference in this reoffer prospectus will
automatically update and supersede information contained in this
reoffer prospectus, including information in previously filed
documents or reports that have been incorporated by reference in
this reoffer prospectus, to the extent the new information differs
from or is inconsistent with the old information. We have filed the
following documents with the SEC and they are incorporated herein
by reference as of their respective dates of filing:
|
1. |
Our Annual Report on
Form 10-K for the year ended December 31, 2021 as filed with
the SEC on March 28, 2022; |
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2. |
Our Quarterly Reports on Form 10-Q
for the quarters ended March 31, 2022 and June 30, 2022 as filed
with the SEC on
May 16, 2022 and
August 12, 2022, respectively; |
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|
3. |
Our Current Reports on Form 8-K and
Form 8-K/A as filed with the SEC on
January 24, 2022,
February 11, 2022, March
2, 2022,
March 30, 2022,
May 25, 2022,
June 10, 2022,
June 28, 2022,
July 6, 2022 and
August 19, 2022. |
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|
4. |
Our definitive proxy statement
Schedule 14A filed with the SEC on April 12, 2022; and |
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5. |
The description of the Company’s
securities registered under Section 12 of the Exchange Act as filed
as
Exhibit 4.1 on Annual Report on Form 10-K for the year ended
December 31, 2021 as filed with the SEC on March 28, 2022. |
All reports and other documents (other than current reports
furnished under Item 2.02 or Item 7.01 of Form 8-K and exhibits
filed in such forms that are related to such items unless such Form
8-K expressly provides to the contrary) we subsequently file
pursuant to Section 13(a), 13(c), 14 or 15(d) of the Exchange Act,
prior to the termination of this offering, will also be
incorporated by reference in this reoffer prospectus and deemed to
be part of this reoffer prospectus from the date of the filing of
such reports and documents.
Any statement contained in a document incorporated or deemed to be
incorporated by reference in this reoffer prospectus shall be
deemed modified, superseded or replaced for purposes of this
reoffer prospectus to the extent that a statement contained in this
reoffer prospectus, or in any subsequently filed document that also
is deemed to be incorporated by reference in this reoffer
prospectus, modifies, supersedes or replaces such statement. Any
statement so modified, superseded or replaced shall not be deemed,
except as so modified, superseded or replaced, to constitute a part
of this reoffer prospectus. None of the information that we
disclose under Items 2.02 or 7.01 of any Current Report on Form 8-K
or any corresponding information, either furnished under Item 9.01
or included as an exhibit therein, that we may from time to time
furnish to the SEC will be incorporated by reference into, or
otherwise included in, this reoffer prospectus, except as otherwise
expressly set forth in the relevant document. Subject to the
foregoing, all information appearing in this reoffer prospectus is
qualified in its entirety by the information appearing in the
documents incorporated by reference.
You may request, orally or in writing, a copy of these documents,
which will be provided to you at no cost (other than exhibits,
unless such exhibits are specifically incorporated by reference),
by contacting us at AIkido Pharma, Inc., One Rockefeller Plaza,
11th Floor, New York, New York 10020, Attention: Chief Financial
Officer, or by telephone at (703) 992-9325. Information about us is
also available at our website at www.aikidopharma.com. However, the
information in our website is not a part of this reoffer prospectus
and is not incorporated by reference.
WHERE YOU CAN FIND MORE
INFORMATION
We have filed a Registration Statement with the Securities and
Exchange Commission under the Securities Act with respect to the
shares of our common stock offered by this reoffer prospectus. This
reoffer prospectus is part of that Registration Statement and does
not contain all the information included in the Registration
Statement. For further information with respect to our common stock
and us, you should refer to the Registration Statement, its
exhibits and the materials incorporated by reference therein.
Portions of the exhibits have been omitted as permitted by the
rules and regulations of the Securities and Exchange Commission.
Statements made in this reoffer prospectus as to the contents of
any contract, agreement or other document referred to are not
necessarily complete. In each instance, we refer you to the copy of
the contracts or other documents filed as exhibits to the
Registration Statement, and these statements are hereby qualified
in their entirety by reference to the contract or document. The
Registration Statement may be inspected and copied at the public
reference facilities maintained by the Securities and Exchange
Commission at Room 1024, Judiciary Plaza, 100 F Street, N.E.,
Washington, D.C. 20549 and the Regional Offices at the Commission
located in the Citicorp Center, 500 West Madison Street, Suite
1400, Chicago, Illinois 60661, and at 233 Broadway, New York, New
York 10279. Copies of those filings can be obtained from the
Commission’s Public Reference Section, Judiciary Plaza, 100 F Fifth
Street, N.E., Washington, D.C. 20549 at prescribed rates and may
also be obtained from the web site that the Securities and Exchange
Commission maintains at http://www.sec.gov. You may also call the
Commission at 1-800-SEC-0330 for more information. We file annual,
quarterly and current reports and other information with the
Securities and Exchange Commission. You may read and copy any
reports, statements or other information on file at the
Commission’s public reference room in Washington, D.C. You can
request copies of those documents upon payment of a duplicating
fee, by writing to the Securities and Exchange Commission.
DISCLOSURE OF COMMISSION
POSITION ON
INDEMNIFICATION FOR SECURITIES LAW VIOLATIONS
Section 145 of the Delaware General Corporation Law, or Delaware
law, inter alia, empowers a Delaware corporation to indemnify any
person who was or is a party or is threatened to be made a party to
any threatened, pending or completed action, suit or proceeding
(other than an action by or in the right of the corporation) by
reason of the fact that such person is or was a director, officer,
employee or agent of the corporation, or is or was serving at the
request of the corporation as a director, officer, employee or
agent of another corporation or other enterprise, against expenses
(including attorneys’ fees), judgments, fines and amounts paid in
settlement actually and reasonably incurred by him in connection
with such action, suit or proceeding if he acted in good faith and
in a manner he reasonably believed to be in or not opposed to the
best interests of the corporation, and, with respect to any
criminal action or proceeding, had no reasonable cause to believe
his conduct was unlawful. Similar indemnity is authorized for such
persons against expenses (including attorneys’ fees) actually and
reasonably incurred in connection with the defense or settlement of
any such threatened, pending or completed action or suit if such
person acted in good faith and in a manner he reasonably believed
to be in or not opposed to the best interests of the corporation,
and provided further that (unless a court of competent jurisdiction
otherwise provides) such person shall not have been adjudged liable
to the corporation. Any such indemnification may be made only as
authorized in each specific case upon a determination by the
stockholders or disinterested directors or by independent legal
counsel in a written opinion that indemnification is proper because
the indemnitee has met the applicable standard of conduct.
Section 145 further authorizes a corporation to purchase and
maintain insurance on behalf of any person who is or was a
director, officer, employee or agent of the corporation, or is or
was serving at the request of the corporation as a director,
officer, employee or agent of another corporation or enterprise,
against any liability asserted against him and incurred by him in
any such capacity, or arising out of his status as such, whether or
not the corporation would otherwise have the power to indemnify him
under Section 145. We maintain policies insuring our officers and
directors against certain liabilities for actions taken in such
capacities, including liabilities under the Securities Act.
Our amended and restated certificate of incorporation, as amended,
and amended and restated bylaws require us to indemnify our
directors to the fullest extent permitted under Delaware law or any
other applicable law in effect, but if such statute or law is
amended, we may change the standard of indemnification only to the
extent that such amended statute or law permits us to provide
broader indemnification rights to our directors. We must indemnify
such officers and employees in the same manner and to the same
extent that we are required to indemnify our directors under our
amended and restated certificate of incorporation and amended and
restated bylaws. Our amended and restated certificate of
incorporation limits the personal liability of a director to us or
our stockholders to damages for breach of the director’s fiduciary
duty. Pursuant to indemnification agreements we entered into with
each of our directors, we are further required to indemnify our
directors to the fullest extent permitted under Delaware law and
our bylaws; provided that each such director shall enjoy the
greater of (i) the advancement and indemnification rights permitted
under our certificate of incorporation and bylaws for directors and
officers as of the date of such indemnification agreement or (ii)
the benefits so afforded by amendments thereto.
Insofar as indemnification for liabilities arising under the
Securities Act of 1933, as amended, may be permitted to directors,
officers or persons controlling us pursuant to the foregoing
provisions, or otherwise, we have been advised that in the opinion
of the Securities and Exchange Commission, such indemnification is
against public policy as expressed in the Securities Act of 1933
and is, therefore, unenforceable.
You should rely only on the information contained in this
document. We have not authorized anyone to provide you with
information that is different. This document may only be used where
it is legal to sell these securities. The information in this
document may only be accurate on the date of this document.
Additional risks and uncertainties not presently known may also
impair our business operations. The risks and uncertainties
described in this document and other risks and uncertainties which
we may face in the future will have a greater impact on those who
purchase our common stock. These purchasers will purchase our
common stock at the market price or at a privately negotiated price
and will run the risk of losing their entire investment.
Up to 294,117 Shares of Common Stock under the AIkido Pharma,
Inc. 2014 Equity Incentive Plan
PROSPECTUS
September 7, 2022
PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
Item 3. Incorporation of Documents by Reference.
The Company hereby incorporates by reference into this Registration
Statement the following documents previously filed with the
SEC:
|
1. |
Our Annual Report on
Form 10-K for the year ended December 31, 2021 as filed with
the SEC on March 28, 2022; |
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|
2. |
Our Quarterly Reports on Form 10-Q
for the quarters ended March 31, 2022 and June 30, 2022 as filed
with the SEC on
May 16, 2022 and
August 12, 2022, respectively; |
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|
|
|
3. |
Our Current Reports on Form 8-K and
Form 8-K/A as filed with the SEC on
January 24, 2022,
February 11, 2022, March
2, 2022,
March 30, 2022,
May 25, 2022,
June 10, 2022,
June 28, 2022,
July 6, 2022 and
August 19, 2022. |
|
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|
4. |
Our definitive proxy statement
Schedule 14A filed with the SEC on April 12, 2022; and |
|
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|
|
5. |
The description of the Company’s
securities registered under Section 12 of the Exchange Act as filed
as
Exhibit 4.1 on Annual Report on Form 10-K for the year ended
December 31, 2021 as filed with the SEC on March 28, 2022. |
All reports and definitive proxy or information statements filed
pursuant to Section 13(a), 13(c), 14 or 15(d) of the Exchange Act
(excluding any information furnished pursuant to Item 2.02 or Item
7.01 of any Current Report on Form 8-K) subsequent to the filing of
this Registration Statement and prior to the filing of a
post-effective amendment which indicates that all securities
offered hereby have been sold or which de-registers all securities
then remaining unsold shall be deemed to be incorporated by
reference into this Registration Statement and to be a part hereof
from the date of filing such documents, except as to specific
sections of such statements as set forth therein. Any statement
contained in a document incorporated or deemed to be incorporated
by reference herein shall be deemed to be modified or superseded
for purposes of this Registration Statement to the extent that a
statement contained in any subsequently filed document which also
is deemed to be incorporated by reference herein modifies or
supersedes such statement.
Item 4. Description of Securities.
Not applicable.
Item 5. Interests of Named Experts and Counsel.
The validity of the shares of common stock offered hereby will be
passed upon by Ellenoff Grossman & Schole LLP, counsel to the
Registrant.
Item 6. Indemnification of Officers and Directors.
Section 145 of the Delaware General Corporation Law, or Delaware
law, inter alia, empowers a Delaware corporation to indemnify any
person who was or is a party or is threatened to be made a party to
any threatened, pending or completed action, suit or proceeding
(other than an action by or in the right of the corporation) by
reason of the fact that such person is or was a director, officer,
employee or agent of the corporation, or is or was serving at the
request of the corporation as a director, officer, employee or
agent of another corporation or other enterprise, against expenses
(including attorneys’ fees), judgments, fines and amounts paid in
settlement actually and reasonably incurred by him in connection
with such action, suit or proceeding if he acted in good faith and
in a manner he reasonably believed to be in or not opposed to the
best interests of the corporation, and, with respect to any
criminal action or proceeding, had no reasonable cause to believe
his conduct was unlawful. Similar indemnity is authorized for such
persons against expenses (including attorneys’ fees) actually and
reasonably incurred in connection with the defense or settlement of
any such threatened, pending or completed action or suit if such
person acted in good faith and in a manner he reasonably believed
to be in or not opposed to the best interests of the corporation,
and provided further that (unless a court of competent jurisdiction
otherwise provides) such person shall not have been adjudged liable
to the corporation. Any such indemnification may be made only as
authorized in each specific case upon a determination by the
stockholders or disinterested directors or by independent legal
counsel in a written opinion that indemnification is proper because
the indemnitee has met the applicable standard of conduct.
Section 145 further authorizes a corporation to purchase and
maintain insurance on behalf of any person who is or was a
director, officer, employee or agent of the corporation, or is or
was serving at the request of the corporation as a director,
officer, employee or agent of another corporation or enterprise,
against any liability asserted against him and incurred by him in
any such capacity, or arising out of his status as such, whether or
not the corporation would otherwise have the power to indemnify him
under Section 145. We maintain policies insuring our officers and
directors against certain liabilities for actions taken in such
capacities, including liabilities under the Securities Act.
Our amended and restated certificate of incorporation and amended
and restated bylaws require us to indemnify our directors to the
fullest extent permitted under Delaware law or any other applicable
law in effect, but if such statute or law is amended, we may change
the standard of indemnification only to the extent that such
amended statute or law permits us to provide broader
indemnification rights to our directors. We must indemnify such
officers and employees in the same manner and to the same extent
that we are required to indemnify our directors under our amended
and restated certificate of incorporation and amended and restated
bylaws. Our amended and restated certificate of incorporation
limits the personal liability of a director to us or our
stockholders to damages for breach of the director’s fiduciary
duty. Pursuant to indemnification agreements we entered into with
each of our directors, we are further required to indemnify our
directors to the fullest extent permitted under Delaware law and
our amended and restated bylaws; provided that each such director
shall enjoy the greater of (i) the advancement and indemnification
rights permitted under our amended and restated certificate of
incorporation and amended and restated bylaws for directors and
officers as of the date of such indemnification agreement or (ii)
the benefits so afforded by amendments thereto.
Item 7. Exemption from Registration Claimed.
All shares of common stock registered hereunder for reoffer or
resale have been or will be issued to our officers, directors,
employees and consultants pursuant to the 2014 Plan and a
restrictive legend is placed on the certificates for the shares of
common stock purchased and transfer stops are placed against such
certificates. Such shares may only be reoffered and sold pursuant
to registration under the Securities Act or pursuant to an
applicable exemption under the Securities Act. As a result, such
offers and sales are exempt from the registration requirements of
the Securities Act pursuant to the provisions of
Section 4(a)(2) of the Securities Act.
Item 8. Exhibits.
Item 9. Undertakings.
(a) The Registrant hereby undertakes:
(1) To file, during any period in which offers or sales are being
made, a post-effective amendment to this Registration
Statement:
(i) To include any prospectus required by
Section 10(a)(3) of the Securities Act;
(ii) To reflect in the prospectus any facts or events arising after
the effective date of the Registration Statement (or the most
recent post-effective amendment thereof) which, individually or in
the aggregate, represent a fundamental change in the information
set forth in the Registration Statement. Notwithstanding the
foregoing, any increase or decrease in volume of securities offered
(if the total dollar value of securities offered would not exceed
that which was registered) and any deviation from the low or high
end of the estimated maximum offering range may be reflected in the
form of prospectus filed with the SEC pursuant to
Rule 424(b) if, in the aggregate, the changes in volume
and price represent no more than 20 percent change in the maximum
aggregate offering price set forth in the “Calculation of
Registration Fee” table in the effective Registration
Statement;
(iii) To include any material information with respect to the plan
of distribution not previously disclosed in the Registration
Statement or any material change to such information in the
Registration Statement;
Provided, however, that paragraphs (a)(1)(a) and
(a)(1)(b) do not apply if the Registration Statement is on
Form S-8 and the information required to be included in a
post-effective amendment by those paragraphs is contained in
periodic reports filed with or furnished to the SEC by the
Registrant pursuant to Section 13 or 15(d) of the
Exchange Act that are incorporated by reference in the Registration
Statement.
(2) That, for the purpose of determining any liability under the
Securities Act, each such post-effective amendment shall be deemed
to be a new Registration Statement relating to the securities
offered therein, and the offering of such securities at that time
shall be deemed to be the initial bona fide offering
thereof.
(3) To remove from registration by means of a post-effective
amendment any of the securities being registered which remain
unsold at the termination of the offering.
(b) The Registrant hereby undertakes that, for purposes of
determining any liability under the Securities Act, each filing of
the Registrant’s annual report pursuant to
Section 13(a) or 15(d) of the Exchange Act (and,
where applicable, each filing of an employee benefit plan’s annual
report pursuant to Section 15(d) of the Exchange Act)
that is incorporated by reference in the Registration Statement
shall be deemed to be a new Registration Statement relating to the
securities offered therein, and the offering of such securities at
that time shall be deemed to be the initial bona fide
offering thereof.
(c) Insofar as indemnification for liabilities arising under the
Securities Act may be permitted to directors, officers and
controlling persons of the Registrant pursuant to the foregoing
provisions, or otherwise, the Registrant has been advised that in
the opinion of the SEC such indemnification is against public
policy as expressed in the Securities Act and is, therefore,
unenforceable. In the event that a claim for indemnification
against such liabilities (other than the payment by the Registrant
of expenses incurred or paid by a director, officer or controlling
person of the Registrant in the successful defense of any action,
suit or proceeding) is asserted by such director, officer or
controlling person in connection with the securities being
registered, the Registrant will, unless in the opinion of its
counsel the matter has been settled by controlling precedent,
submit to a court of appropriate jurisdiction the question whether
such indemnification by it is against public policy as expressed in
the Securities Act and will be governed by the final adjudication
of such issue.
SIGNATURES
Pursuant to the requirements of the Securities Act of 1933, the
registrant certifies that it has reasonable grounds to believe that
it meets all of the requirements for filing on Form S-8 and has
duly caused this Registration Statement to be signed on its behalf
by the undersigned, thereunto duly authorized, in the City of New
York, State of New York, on September 7, 2022.
|
AIKIDO PHARMA, INC. |
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|
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/s/
Anthony Hayes |
|
Name: |
Anthony Hayes |
|
Title: |
Chief Executive Officer |
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(Principal Executive Officer,
Principal Financial Officer and
Principal Accounting Officer)
|
POWER OF ATTORNEY
KNOW ALL PERSONS BY THESE PRESENTS, that each person whose
signature appears below does hereby constitute and appoint Michael
Rice with full power of substitution, such person’s true and lawful
attorneys-in-fact and agents for such person, with full power and
authority to do any and all acts and things and to execute any and
all instruments which said attorneys and agents, and any one of
them, determine may be necessary or advisable or required to enable
said corporation to comply with the Securities Act of 1933, as
amended, and any rules or regulations or requirements of the
Securities and Exchange Commission in connection with this
Registration Statement. Without limiting the generality of the
foregoing power and authority, the powers granted include the power
and authority to sign the names of the undersigned officers and
directors in the capacities indicated below to this Registration
Statement, to any and all amendments, both pre-effective and
post-effective, and supplements to this Registration Statement, and
to any and all instruments or documents filed as part of or in
conjunction with this Registration Statement or amendments or
supplements thereof, and each of the undersigned hereby ratifies
and confirms that all said attorneys and agents, or any one of
them, shall do or cause to be done by virtue hereof. This Power of
Attorney may be signed in several counterparts.
Pursuant to the requirements of the Securities Act of 1933, as
amended, this Registration Statement has been signed by the
following persons on behalf of the Registrant in the capacities and
on the dates indicated.
Signature |
|
Title |
|
Date |
|
|
|
/s/
Anthony Hayes |
|
Chief
Executive Officer |
|
September
7, 2022 |
Anthony
Hayes |
|
(Principal Executive Officer,
Principal Accounting Officer,
Principal Financial Officer and Director)
|
|
|
|
|
|
/s/
Robert J. Vander Zanden |
|
Director
and Chairman of the Board of |
|
September
7, 2022 |
Robert
J. Vander Zanden |
|
Directors |
|
|
|
|
|
|
|
/s/
Tim S. Ledwick |
|
Director |
|
September
7, 2022 |
Tim
S. Ledwick |
|
|
|
|
|
|
|
/s/
Paul LeMire |
|
Director |
|
September
7, 2022 |
Paul
LeMire |
|
|
|
|
|
/s/
Robert Dudley |
|
Director |
|
September
7, 2022 |
Robert
Dudley |
|
|
|
|
|
|
|
/s/
Gregory Blattner |
|
Director |
|
September
7, 2022 |
Gregory
Blattner |
|
|
|
|
|
|
|
|
|
/s/
Kyle Wool |
|
Director |
|
September
7, 2022 |
Kyle
Wool |
|
|
|
|
|
|
|
|
|
/s/
Soo Yu |
|
Director |
|
September
7, 2022 |
Soo
Yu |
|
|
|
|
II-4
Alkido Pharma (NASDAQ:AIKI)
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Alkido Pharma (NASDAQ:AIKI)
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